UK-based Stable Micro Systems, which specialises in the physical characterisiation of pharmaceutical and medical products, has launched the innovative Bilayer Tablet Shear rig.
Ths new attachment for the company's TA.XTPlus texture analyser has been developed to help manufacturers gauge and optimise the stability of tablets that contain isolated immediate and controlled release component layers.
Ensuring that one tablet layer does not impact on the other is instrumental to the remedial benefits of bilayer medication, but isolating two release components in separate layer formations can prove complex for manufacturers. The characteristics of each active pharmaceutical ingredient in a bilayer tablet often differ, leading to problems in tablet composition which may in turn result in cross-contamination.
Common issues include layer separation, insufficient hardness and inaccurate individual layer weight control. By testing the strength of bilayer tablets, pharmaceutical manufacturers are able to identify weaknesses and improve quality and stability.
The Bilayer Tablet Shear Rig is attached to the TA.XTPlus texture analyser, which uses Exponent software to analyse layer separation. The tablet sample is placed in the central cavity of a guillotine-type blade, which is then compressed until the two components of the tablet are sheared apart. The force taken to shear the tablet, as well as the distance to failure, is calculated. The lower the force required to shear the tablet, the more likely it is that the layers will fail during manufacture, packing or consumption.
Visual characterisation of the fracture surface enables quantification of the percentage of each fracture failure, which is important in enabling manufacturers to optimise adhesion between the two tablet components.